BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24363762 · Received February 17, 2026

    Report

    Report Number
    2210968-2026-01659
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    October 16, 2025
    Report Date
    February 17, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: AESTHET SURG J. 2025 OCT 16;45(11):1109-1114. HTTPS://DOI.ORG/10.1093/ASJ/SJAF115 PMID: 40577206.

    Description of Event or Problem · 0

    TITLE: THE WONDER OF SUTURELESS MÜLLERECTOMY. THE AIM OF THIS STUDY IS TO EVALUATE THE EFFICACY AND SAFETY OF SUTURELESS MÜLLER MUSCLE¿CONJUNCTIVAL RESECTION (MMCR) AS A TREATMENT FOR MODERATE TO SEVERE PTOSIS, AND TO ASSESS POSTOPERATIVE EYELID SYMMETRY AND SURGICAL SUCCESS RATES. BETWEEN (B)(6) 2023, A TOTAL OF 252 EYES OF 147 PATIENTS WHO UNDERWENT SUTURELESS MMCR WERE INCLUDED IN THE STUDY. THE MEAN AGE OF THE PATIENTS WAS 64.95 [11.52] YEARS; 96 PATIENTS (65%) WERE FEMALE AND 51 WERE MALE. NO SUTURES WERE PLACED UNLESS A >0.5 MM WOUND GAP PERSISTED, IN WHICH CASE A 7-0 VICRYL MATTRESS SUTURE WAS PLACED. REPORTED COMPLICATIONS ARE : -WOUND DEHISCENCE (N=3) TREATMENT: ALL OF WHICH WERE SURGICALLY REPAIRED WITHOUT SEQUELAE. IN CONCLUSION, SUTURELESS MMCR DEMONSTRATED HIGH SUCCESS RATES AND POSTOPERATIVE SYMMETRY, WITH LOW COMPLICATION RATES, SUPPORTING ITS EFFICACY AS A RELIABLE AND MINIMALLY INVASIVE PROCEDURE FOR THE TREATMENT OF PTOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423471 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention